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Completed

NCT Number: NCT02064543

Measurement of Gait Using Opal APDM and Gait Mat in Parkinsonism

The project is a prospective trial comparing Zeno/GAITRite and APDM® in a cohort of persons living with parkinsonian disorders. Ambulatory patients with a parkinsonian syndrome and who are able to provide informed consent will participate in the assessments.

Outcome variables include selected gait and balance parameters such as cadence, gait-cycle, stride-length, stride-velocity, turning duration, turning steps, postural sway and anticipatory postural control. These parameters will be measured by the portable inertial sensors developed by APDM® and the Zeno/GaitRite.

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Key information

Conditions

Parkinsonism Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

About this study

Testing

Participants after screening and consenting will:

  • Have their height measured and fit with the APDM Opals (each device is a two inch square attached by velcro), one device is attached to each leg, each arm, and the trunk and chest and receive an introduction to walking on the gait mat.
  • Participants are then asked to walk at a self selected walking speed down the gait mat. The participants will complete multiple passes (8-10 passes, total 75-100 feet) across the gait mat while wearing the APDM units to concurrently collect all temporal and spatial data needed to answer the research question. The Zeno mat is the intended primary gait mat for this study. The GaitRite will only be utilized in the case of a technical issue with the Zeno in order to insure completion of the data collection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults between the ages of 18 and 80 years of age with a primary diagnosis of PD and similar parkinsonian syndromes
  • Individuals able to walk 100 feet independently, with or without the use of an assistive device (walker, cane) and follow simple instructions.
  • Individuals with sufficient physiological systemic support to participate in the study protocol

Exclusion criteria

  • Inability to speak English secondary to the need to understand and follow multistep directions
  • A secondary diagnosis (musculoskeletal, cardiopulmonary, neurological) that excludes participation in the study
  • Inability to ambulate 100 feet independently with or without an assistive device.
  • Inability to follow simple instructions necessary for completion of the testing tasks.

Treatment and study plan

GAITRite

Other

mobility test assessing gait parameters

ADPM

Other

mobility test assessing gait parameters

Primary outcomes

  1. gait parameters

    Time frame: one year

    Outcome variables include selected gait and balance such as cadence

  2. gait parameters

    Time frame: one year

    Outcome variables include selected gait and balance such as stride-length

  3. gait parameters

    Time frame: one year

    Outcome variables include selected gait and balance such as stride-velocity

  4. gait parameters

    Time frame: one year

    Outcome variables include selected gait and balance such as turning duration

  5. gait parameters

    Time frame: one year

    Outcome variables include selected gait and balance such as turning steps

  6. gait parameters

    Time frame: one year

    Outcome variables include selected gait and balance such as postural sway

  7. gait parameters

    Time frame: one year

    Outcome variables include selected gait and balance such as anticipatory postural control

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Measurement of Gait Using the Opal APDM and an Instrumented Gait Mat in Persons With Parkinsonism

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Feb 17, 2014
Registry last updated
Sep 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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